A Clinical Study on the Analysis of Risk Factors for the Occurrence of PD-1/PD-L1 Inhibitor-associated Liver Injury in Lung Cancer Patients

NCT ID: NCT06402981

Last Updated: 2024-05-07

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 2000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2025-06-30

Brief Summary

The goal of this observational study is to investigate the risk factors of PD-1/PD-L1 inhibitor-associated liver injury, to construct a prediction model for the occurrence of liver injury. The main questions it aims to answer are:

• Exploring risk factors for liver injury.
• Constructing a Predictive Model for the Occurrence of Liver Injury in PD-1/PD-L1 Inhibitor-Related Liver Injury.
• Improving immunotherapy protocols for lung cancer patients.

Detailed Description

PD-1/PD-L1 inhibitors have achieved surprising results in lung cancer treatment and have been approved by the FDA for the treatment of different types of lung cancer. Their overall toxicity is lower than that of standard chemotherapy, but a number of immune-related adverse events have been reported clinically. Liver injury is one of the leading causes of death from adverse events due to PD-1/PD-L1 inhibitors. The occurrence of immune-related liver damage has an important impact on the tumor treatment and prognosis of patients. Most of the current domestic and international studies focus on the overall description and study of PD-1/PD-L1 antibody-related adverse events, and there is no definitive description of the risk factors for the development of immune-related liver injury in lung cancer patients. The aim of this project is to review the clinical data of lung cancer patients treated with PD-1/PD-L1 inhibitors from 2020.01 to 2024.06, to investigate the risk factors of PD-1/PD-L1 inhibitor-associated liver injury, to construct a prediction model for the occurrence of liver injury, and to take measures to prevent the occurrence of fatal immune liver injury, which is of great significance to the immunotherapy of clinical tumor patients. It is of great significance to the immunotherapy of clinical tumor patients.

Conditions

Immune Checkpoint Inhibitors; Liver Injury

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

liver damage group

Lung cancer patients using PD-1/PD-L1 inhibitors with hepatic injury as determined by the hepatic index criteria set by the Common Terminology Criteria for Adverse Events (CTCAE 5.0)

High risk prediction model for liver injury

Intervention Type: OTHER

Risk Prediction Model for Liver Injury After Use of PD-1/PD-L1 Inhibitors

No liver damage group

Lung cancer patients with PD-1/PD-L1 inhibitors who are judged not to have liver injury according to the liver index criteria set by the Common Terminology Criteria for Adverse Events (CTCAE 5.0)

High risk prediction model for liver injury

Intervention Type: OTHER

Risk Prediction Model for Liver Injury After Use of PD-1/PD-L1 Inhibitors

Interventions

High risk prediction model for liver injury

Risk Prediction Model for Liver Injury After Use of PD-1/PD-L1 Inhibitors

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Lung cancer patients who have received at least one and more PD-1/PD-L1 inhibitor treatments;

2. Gender is not limited, age 18-80 years old

Exclusion Criteria

1. Severe liver injury prior to immunotherapy (elevation of transaminases, alkaline phosphatase, and glutamyl aminotransferase more than 5 times the upper limit of normal).

2. Patients who, in the opinion of the investigator, are not suitable for participation in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Jiajia Chen

Chief Physician of the First Affiliated Hospital,Zhejiang University School of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jiajia Chen

Role: PRINCIPAL_INVESTIGATOR

Zhejiang University

Locations

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jiajia Chen

Role: CONTACT

Jiajiatale0@zju.edu.cn

+8615967109232

Other Identifiers

IIT20240464A

Identifier Type: -

Identifier Source: org_study_id